BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNESIUM

    MDR report key: 2141711 · Received June 27, 2011

    Report

    Report Number
    1823260-2011-03484
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 27, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGJ
    PMA / PMN Number
    K954992
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE USER EXPERIENCED MAGNESIUM IMPRECISION AND RECEIVED A QUESTIONABLE RESULT FOR ONE PATIENT SAMPLE FROM THE COBAS C501 ANALYZER (B)(4). THE INITIAL RESULT WAS 3.91 MG/DL AND WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED ON AN INTEGRA 800 ANALYZER AND THE RESULT WAS 2.0 MG/DL. THE PATIENT WAS NOT ADVERSELY AFFECTED AS A CORRECTED REPORT WAS SENT IMMEDIATELY. UPON EVALUATION OF THE ANALYZER, THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A FLUIDIC SYSTEM FAILURE DUE TO THE GEAR PUMP PRESSURE BEING MISADJUSTED WHICH CAUSED THE DISPENSE VOLUMES OF THE SAMPLE AND REAGENT PROBES TO BE LOW. HE ADJUSTED THE GEAR PUMP PRESSURE. TO VERIFY THE ANALYZER OPERATION, THE USER RAN QUALITY CONTROL WITH RESULTS WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAGNESIUM PHOTOMETRIC METHOD, MAGNESIUM JGJ ROCHE DIAGNOSTICS NA 64112301

    Patients

    Seq Age Sex Outcome Treatment
    1 063 YR